Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial

NCT ID: NCT06039865

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-01-21

Brief Summary

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The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.

Detailed Description

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After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio.

Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Intervention

Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.

Group Type EXPERIMENTAL

Immediate Intervention

Intervention Type BEHAVIORAL

Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.

Waitlist control

Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.

Group Type OTHER

Waitlist control

Intervention Type BEHAVIORAL

Participants only receive usual care from the sleep center.

Interventions

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Immediate Intervention

Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.

Intervention Type BEHAVIORAL

Waitlist control

Participants only receive usual care from the sleep center.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Prescribed PAP therapy from the sleep center for \> 1 week
* Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for \> 1 week
* Non-adherent with PAP therapy
* Willing to continue using current PAP device for 28 days continuously
* Have an electronic device compatible with the wearable app

Exclusion Criteria

* Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder
* Use home oxygen
* Unstable medical or psychiatric illness
* Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)
* Planned surgery or hospitalization during study period
* Planned extensive travel during study period
* History of repeated non-attendance at clinic visits
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Constance Fung

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Constance H. Fung, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

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VA Greater Los Angeles Healthcare System

North Hills, California, United States

Site Status

Countries

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United States

References

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Mak S, Ash G, Liang LJ, Der-McLeod E, Ghadimi S, Kewalramani A, Naeem S, Zeidler M, Fung C. Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 19;13:e60769. doi: 10.2196/60769.

Reference Type DERIVED
PMID: 39207912 (View on PubMed)

Other Identifiers

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20233750

Identifier Type: -

Identifier Source: org_study_id

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